Recalls / Class III
Class IIID-0955-2016
Product
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
- Affected lot / code info
- Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
Why it was recalled
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 741.171 kg
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-03-11
- FDA classified
- 2016-06-02
- Posted by FDA
- 2016-06-08
- Terminated
- 2017-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0955-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.